- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05214534
Contribution of SuPAR for Patients in a Situation of Uncertainty Downstream of Emergencies (SuPAR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SuPAR (Soluble urokinase Plasminogen Activator Receptor) is a non-specific prognostic blood biomarker related to inflammation. An elevated SuPAR value reflects significant chronic inflammation and predicts a risk of negative outcome and even short-term mortality (intra-hospital, 30 days, 90 days). Conversely, a low SuPAR value is a strong indicator of good prognosis and low risk of readmission. It is therefore of interest to know a patient's SuPAR blood level to enable the clinician to decide whether the patient should be admitted or discharged. SuPAR has been shown to be the best prognostic marker associated with the presence and progression of disease and risk of mortality. The use of SuPAR in clinical routine adds significant complementary information to the standard Early Warning Score assessment and to the classical parameters such as CRP, PCT, Lactate, ALT, Bilirubin, and CBC in the pre-admission of acute patients.
Patients admitted to the emergency department will receive their usual management. We will test the added value of the SuPAR assay in the prognosis of patients' outcome at discharge.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Clermont-Ferrand, France
- Chu Clermont-Ferrand
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient, male or female, over 18 years old
- Admitted to the emergency department of the Clermont-Ferrand University Hospital for a medical reason,
- Classified as FRENCH II or III by the nurse organizer of the reception management
- Necessity of clinical observation in the Short Term Hospitalization Unit for final orientation decision
- Requires a blood test upon arrival in the emergency department
- Able to give informed non-opposition to participate in the research.
- Affiliation to a Social Security system
Exclusion Criteria:
- Patient under guardianship or curatorship
- Pregnant and breast feeding woman
- Patient admitted for psychiatric pathology
- Patient with a limitation of therapeutics
- Refusal to participate
- Patient hospitalized because of a particular social context
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Experimental
Retrospective analysis of the correlation between SuPAR measurement and patient outcome after hospitalization
|
The supar values will be measured afterwards on the tube bottoms of the patients included in the study from their usual collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between blood supar levels and patient outcome at discharge
Time Frame: When the excepted 150 patients will be included, estimated 6 months
|
Relation between blood supar levels measured and patient outcome at discharge evaluated as : return home = good evolution; hospitalization = bad evolution; admission to an intensive care unit or death = unfavorable evolution
|
When the excepted 150 patients will be included, estimated 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
National Early Warning Score 2 (NEWS2)
Time Frame: Hour 0
|
Score allowing the classification of the urgency of a patient.
The minimum value is 0 and the maximum value is 20.
Higher scores mean a worse outcome
|
Hour 0
|
Modified Early Warning Score (MEWS)
Time Frame: Hour 0
|
Score allowing the classification of the urgency of a patient.
The minimum value is 0 and the maximum value is 17.
Higher scores mean a worse outcome
|
Hour 0
|
Blood supar levels
Time Frame: When the excepted 150 patients will be included, estimated 6 months
|
the supar values are classifies into three categories : < 3 ng/ml : supports the referral decision.
the patient's general condition is good and the prognosis is high 3-6 ng/ml : presence of pathologies and comorbidity factors.
readmissions and high mortality beyond 6 months >6 ng/ml : requires special clinical attention, high risk of mortality
|
When the excepted 150 patients will be included, estimated 6 months
|
Blood CRP value
Time Frame: Hour 0
|
the CRP value will be assessed during the blood test performed as part of the classical management when the patient arrives in the emergency room
|
Hour 0
|
Cardiac frequency
Time Frame: Hour 0
|
cardiac frequency will be evaluated when the patient arrives in the emergency service as part of the classical management
|
Hour 0
|
Respiratory rate
Time Frame: Hour 0
|
respiratory rate will be evaluated when the patient arrives in the emergency service as part of the classical management
|
Hour 0
|
Temperature
Time Frame: Hour 0
|
the temperature will be evaluated when the patient arrives in the emergency service as part of the classical management
|
Hour 0
|
Systolic blood pressure
Time Frame: Hour 0
|
systolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management
|
Hour 0
|
Diastolic blood pressure
Time Frame: Hour 0
|
diastolic blood pressure will be evaluated when the patient arrives in the emergency service as part of the classical management
|
Hour 0
|
French triage
Time Frame: Hour 0
|
French Emergency Nurses Classification in Hospitals (FRENCH) ranks priorities from 5 to 1 (from least urgent to most urgent) according to prognosis and complexity/severity of the medical condition
|
Hour 0
|
Main diagnosis retained by the physician
Time Frame: at the end of hospitalization
|
Main diagnosis retained
|
at the end of hospitalization
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fares MOUSTAFA, University Hospital, Clermont-Ferrand
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI 2021 MOUSTAFA
- 2021-A01930-41 (Other Identifier: 2021-A01930-41)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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